Qualification/validation

testo Saveris Qualification/validation

The risk-based qualification and validation of systems and processes ensures the long-term stability and robustness of production processes and is obligatory for regulatory purposes in GxP-relevant industries (especially pharma). Testo can assist you with your qualification and validation projects or handle the entire process.

Interested? We look forward to hearing from you.

How to contact us.

Do you have any questions?
We're happy to help you.

Challenge

  • Create and implement risk-based qualifications/validations
  • Ensure quality in GxP-regulated industries such as pharma, medical technology and life sciences
  • Comply with regulatory standards:

    • AMG, AMWHV, MPG
    • EU GMP Guidelines
    • 21 CFR 210+211+11
    • EMA Guidelines
    • ISO 13485

Solution/service

  • Conception and consultancy for risk-based qualification and validation
  • Manpower and support throughout all qualification and validation phases
  • Master plan and final report
  • Risk management in accordance with ICH Q9
  • Carrying out all tests and measurements
  • GxP-compatible documentation
  • Project coordination

Reasons to choose us

  • Tailored, needs-based service
  • Modern measuring technology
  • GxP-compatible documentation systems for optimum fulfilment of compliance